Bictegravir/TAF/FTC in Women

The single-pill combination of bictegravir (BIC) with tenofovir alafenamide (TAF) and emtricitabine (FTC), recently approved by the FDA, has been shown in four Phase III trials to be effective as initial therapy and as a switch regimen in patients with stably suppressed HIV RNA and no resistance to BIC, TAF, or FTC. In these studies, <15% of participants were women. At CROI 2018, researchers presented results of a switch trial done in women. This was an international open-label study in which 470 women with virologic suppression on a regimen consisting of elvitegravir/cobicistat/tenofovir/FTC (95%) or atazanavir + ritonavir + TDF/FTC (5%) were randomized to switch to BIC/TAF/FTC or to stay on their baseline regimen. At week 48, 96% of the switch group and 95% of the comparator group maintained HIV RNA <50 copies/mL, with no differences in efficacy by race or geographic region. No resistance emerged in the few subjects with virologic failure on BIC, while 1 subject in the baseline regimen group developed M184M/I/V mutations. No significant differences were noted in rates of adverse events or in eGFR or proteinuria.

Clinical Bottom Line

This study showed that BIC/TAF/FTC is effective and safe as a switch regimen in women with stable viral suppression and no predicted ARV resistance. These results are not surprising but nonetheless are reassuring. Further investigation will be needed to determine whether BIC/TAF/FTC is safe for use during pregnancy.

Susa Coffey is medical editor of the NCRC. She is a Professor of Medicine at UCSF in the Division of HIV, Infectious Diseases and Global Medicine and a longtime clinician and educator in HIV at San Francisco General Hospital clinic (“Ward 86”). She also is medical editor of HIV InSite. Dr. Coffey is Co-Lead of the RAPID clinical program at Ward 86, San Francisco General Hospital and the Chair of the RAPID Committee of San Francisco's Getting to Zero campaign.

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This project is supported by the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS) under grant number U1OHA28686 (AIDS Education and Training Centers National Coordinating Resource Center) awarded to the François-Xavier Bagnoud Center, Rutgers University School of Nursing. No percentage of this project was financed with non-governmental sources. This information or content and conclusions are those of the authors and should not be construed as the official position or policy of, nor should any endorsements be inferred by HRSA, HHS, or the U.S. Government.